Exactech, Inc.: GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 42, REF 106-22-42; b. ALL POLYETHYLENE ACETABULAR CU

Hazard

Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.

Details from the source

Reason for recall: Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear. Distribution: Worldwide distribution: US (nationwide) and OUS (foreign) countries of: ARGENTINA, BRAZIL, CHILE, CHINA, COLOMBIA, ECUADOR, GREECE, GUATEMALA, INDIA, LEBANON PORTUGAL,PUERTO RICO,SPAIN Quantity: 4956 devices Lot/code info: a. REF 106-22-42, GUDID 10885862014337, Serial Numbers: 609855, 609856, 609857, 609858, 609859, 609860, 609862, 609863, 609864, 609865, 609867, 609868, 609869, 609870, 609871, 609873, 609874, 609878, 609879, 609880, 914353, 914354, 914355, 914356, 914357, 914358, 914359, 914360, 914361, 914362, 914363, 914364, 996721, 996722, 996723, 996724, 996725, 996726, 996727, 996728, 996730, 996731, 996732, 996733, 996734, 996735, 996736, 996737, 996738, 996739, 1049244, 1049245, 1049246, 1049247, 1068758, 1068759, 1068760, 1068761, 1068762, 1068763, 1068765, 1068766, 1068767, 1068768, 1068769, 1068770, 1068771, 1068772, 1068773, 1068774, 1068775, 1068776, 1068777, 1068778, 1229946, 1229947, 1229948, 1229949, 1229950, 1229951, 1229952, 1229953, 1229954, 1229955, 1229956, 1332136, 1332137, 1332138, 1332139, 1332140, 1358473, 1358475, 1358476, 1358477, 1358478, 1514277, 1514278, 1514279, 1514280, 1514281, 1514282, 1514283, 1514284, 1514285, 1514286, 1514287, 1514288, 1514289, 1514290, 1514291, 1514292, 1514293, 1514296, 1695633, 1695634, 1695635, 1695636, 1695637, 1695638, 1695639, 1695640, 1695642, 1695643, 1695644, 1695645, 1695646, 1695647, 1695648, 1695649, 1695650, 1695651, 1695652, 1919868, 1919869, 1919870, 1919871, 1919872, 1919873, 1919874, 1919875, 2017771, 2017772, 2172423, 2172424, 2172425, 2180478, 2180479, 2180480, 2180481, 2221234, 2221235, 2221236, 2221238, 2276137, 2276138, 2276139, 2291938, 2291939, 2291940, 2291941, 2333843, 2333844, 2375620, 2375621, 2375622, 2375623,

UPC codes

10885862014337, 10885862014344, 10885862014351, 10885862014368, 10885862014375, 10885862014382, 10885862014603, 10885862014610

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.